Recalls / Class III
Class IIID-1152-2014
Product
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
- Brand name
- Triamcinolone Acetonide
- Generic name
- Triamcinolone Acetonide
- Active ingredient
- Triamcinolone Acetonide
- Route
- Topical
- NDCs
- 0168-0002, 0168-0003, 0168-0004
- FDA application
- ANDA085692
- Affected lot / code info
- Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15
Why it was recalled
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Recalling firm
- Firm
- Fougera Pharmaceuticals Inc.
- Manufacturer
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 60 Baylis Rd, N/A, Melville, New York 11747-3838
Distribution
- Quantity
- 493,192 tubes
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-01-29
- FDA classified
- 2014-03-07
- Posted by FDA
- 2014-03-19
- Terminated
- 2015-12-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1152-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.